Label: CALMING PRIMER SPF 20- titanium dioxide and zinc oxide liquid
- NDC Code(s): 68078-040-01
- Packager: Colorescience
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 7, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- Reapply:
- After 40 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- Children under 6 months: ask a doctor.
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Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:- Limit time in the sun, especially from 10 a.m.– 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive ingredients
Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber) Fruit Extract, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Dimethicone, Triethoxycaprylylsilane, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CALMING PRIMER SPF 20
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 54 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 54 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone Crosspolymer (450000 MPA.S AT 12% IN Cyclopentasiloxane) (UNII: UF7620L1W6) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M) Dimethiconol (100000 CST) (UNII: OSA9UP217S) ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Citrus Paradisi Seed (UNII: 12F08874Y7) Phenoxyethanol (UNII: HIE492ZZ3T) Triethoxycaprylylsilane (UNII: LDC331P08E) Ascorbic Acid (UNII: PQ6CK8PD0R) Green Tea Leaf (UNII: W2ZU1RY8B0) PALMARIA PALMATA (UNII: 7832HOY4ZQ) FERRIC OXIDE RED (UNII: 1K09F3G675) Opuntia Ficus-Indica Stem (UNII: MUD8892KHL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Benzoic Acid (UNII: 8SKN0B0MIM) Dehydroacetic Acid (UNII: 2KAG279R6R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-040-01 1 in 1 CARTON 01/01/2020 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2020 Labeler - Colorescience (128731929)
